If you are eligible for the Co-Pay Savings Card, but your pharmacy does not accept it, a rebate form is available to reimburse you for the co-pay amount. Instructions on how to redeem are included on the form.
It is not known if XELJANZ is safe and effective in children or in people with Hepatitis B or C.
XELJANZ is not recommended for people with severe liver problems.
If you are eligible for the Co-Pay Savings Card, but your pharmacy does not accept it, a rebate form is available to reimburse you for the co-pay amount. Instructions on how to redeem are included on the form.
If you have questions, concerns or comments, please call our XELJANZ Information Center toll-free at
Patients should always ask their doctors for medical advice about adverse events. You are encouraged to report adverse events related to Pfizer products by calling
By using the XELJANZ/XELJANZ XR Co-pay Savings Card (the “Card”), you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions.
If you have questions or are in need of additional support, call
XELJANZ may cause serious side effects, including:
Serious infections. XELJANZ can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
Your healthcare provider should test you for TB before starting and during XELJANZ treatment, and monitor you closely for signs and symptoms of TB infection during treatment.
You should not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). People taking the higher dose (
Before starting XELJANZ, tell your healthcare provider if you:
think you have an infection or have symptoms of an infection, such as fever, sweating, or chills; cough; blood in phlegm; warm, red, or painful skin or sores on your body; burning when you urinate or urinating more often than normal; muscle aches; shortness of breath; weight loss; diarrhea or stomach pain; or feeling very tired
are being treated for an infection
get a lot of infections or have infections that keep coming back
have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
have TB, or have been in close contact with someone with TB
live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use XELJANZ. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common
have or have had Hepatitis B or C
After starting XELJANZ, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ can make you more likely to get infections or make worse any infection that you have.
Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ
Cancer and immune system problems. XELJANZ may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen in patients taking XELJANZ. People taking the higher dose (
Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).
Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ
Stop taking XELJANZ/ XELJANZ XR and tell your healthcare provider right away if you have any signs and symptoms of a blood clot such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the leg or arm
Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away and a change in your bowel habits.
Serious allergic reactions have happened in patients taking XELJANZ. If you have swelling of your lips, tongue, throat, or get hives, stop XELJANZ and call your healthcare provider right away.
Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ, and while you take XELJANZ, to check for the following side effects:
Changes in lymphocyte counts. Lymphocytes are white blood cells that help the body fight off infections.
Low neutrophil counts. Neutrophils are white blood cells that help the body fight off infections.
Low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired.
Your healthcare provider should routinely check certain liver tests.
You should not receive XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your XELJANZ treatment for a period of time if needed because of changes in these blood test results.
You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start XELJANZ, and as needed after that.
What should I tell my healthcare provider before taking XELJANZ?
Before taking XELJANZ, tell your healthcare provider about all of your medical conditions, including if you:
have an infection
have had blood clots in the veins of your legs, arms, or lungs, or clots in the arteries in the past.
have liver problems
have kidney problems
have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
have had a reaction to tofacitinib or any of the ingredients in XELJANZ
have recently received or are scheduled to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines
plan to become pregnant or are pregnant. XELJANZ may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ. It is not known if XELJANZ will harm an unborn baby.
Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at
plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take XELJANZ or breastfeed. You should not do both. After you stop your treatment with XELJANZ, do not start breastfeeding again until 18 hours after your last dose of XELJANZ.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider about any other medicines you take to treat your ulcerative colitis. You should not take tocilizumab (Actemra®), etanercept (Enbrel®), adalimumab (Humira®), infliximab (Remicade®), rituximab (Rituxan®), abatacept (Orencia®), anakinra (Kineret®), certolizumab (Cimzia®), golimumab (Simponi®), ustekinumab (Stelara®), secukinumab (Cosentyx®), vedolizumab (Entyvio®), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ. Taking XELJANZ with these medicines may increase your risk of infection.
Tell your healthcare provider if you are taking medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.
Taking XELJANZ
Take XELJANZ 2 times a day with or without food.
Do not take XELJANZ XR for ulcerative colitis.
What are other possible side effects of XELJANZ? XELJANZ may cause serious side effects, including Hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ. Your healthcare provider may do blood tests before you start treatment with XELJANZ and while you are using XELJANZ. Tell your healthcare provider if you have any of the following symptoms of a possible Hepatitis B or C infection: feel very tired, little or no appetite,
Common side effects of XELJANZ in ulcerative colitis patients include nasal congestion, sore throat, and runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).
What is XELJANZ? XELJANZ (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:
Adults with moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated
It is not known if XELJANZ is safe and effective in children or in people with Hepatitis B or C.
XELJANZ is not recommended for people with severe liver problems.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
It is not known if XELJANZ is safe and effective in children or in people with Hepatitis B or C.
XELJANZ is not recommended for people with severe liver problems.
PFIZER PATIENT ASSISTANCE PROGRAM ELIGIBILITY CRITERIA
INTERIM CARE Rx PROGRAM TERMS & CONDITIONS
VOUCHER TERMS AND CONDITIONS
By redeeming this voucher, you acknowledge that you currently meet the eligibility criteria and will comply with the terms & conditions described below:
*MA residents may select their pharmacy. Otherwise, this free trial will be supplied through XELSOURCE.
CO-PAY CARD TERMS AND CONDITIONS
By using the XELJANZ/XELJANZ XR Co-pay Savings Card (the “Card”), you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions.
If you have questions or are in need of additional support, call 1-844-935-5269 or visit www.XELJANZ.com.
XSAVINGS MOBILE TEXT PROGRAM TERMS & CONDITIONS
User texts "XPROGRAM" to short code 50336.
Text HELP for help, STOP to opt out.
Patients may receive up to 10 messages per month.
Message and data rates may apply.
1. By opting into the XSAVINGS mobile texting program (Program), you consent to receive up to 10 text messages and/or push notifications from Pfizer Inc. Such messages may be marketing or non-marketing messages and may include co-pay related information, fill confirmation, website information, etc. Messages may be delayed or undelivered for various factors. TrialCard, carriers (including, but not limited to, T-Mobile) and any service providers utilized by TrialCard to send messages are not liable for delayed or undelivered messages.
2. To stop receiving text messages, text STOP to 50336. DOING SO WILL ONLY OPT YOU OUT OF THIS PROGRAM; you will remain opted in to any other Pfizer Inc text message program(s) into which you opted separately.
3. To request more information or to obtain help, text HELP to 50336. You can also call customer service at 1-844-935-5269.
4. You represent that you are the account holder for the mobile telephone number(s) that you provide to opt into the Program. You are responsible for notifying Pfizer Inc immediately if you change your mobile telephone number. You may notify Pfizer Inc of a number change by calling 1-844-935-5269.
5. Message and data rates may apply to each text message sent or received in connection with the texting program, as provided in your mobile telephone service rate plan (please contact your mobile telephone carrier for pricing plans). Applicable roaming charges may apply. Charges are both billed and payable to your mobile service provider or deducted from your prepaid account. Pfizer Inc does not impose a separate fee for sending text messages.
6. Data obtained from you in connection with this Program may include your telephone number, your carrier's name, and details of the message (date, time, and content). Pfizer Inc may use this information to contact you and to provide the services you request.
7. For information on data collection and use, please read our full corporate Privacy Policy (https://www.pfizer.com/Privacy), which is incorporated by reference into these Terms.
8. Pfizer Inc will not be liable for any delays in the receipt of any SMS messages, as delivery is subject to effective transmission from your network operator.
9. This Program is available only on these US participating mobile carriers: Verizon Wireless, Sprint, Boost Mobile, T-Mobile, AT&T, Atlantic Tele-Network International (ATNI), Alaska Communications Systems (ACS), ASTAC, Bandwidth.com (includes Republic Wireless), Blue Wireless, Bluegrass Cellular, Breakaway Wireless, Brightlink, C Spire Wireless (aka Cellular South), Carolina West Wireless, CellCom, Cellone Nation, Cellular One of N.E. Arizona, Chariton Valley Cellular, Chat Mobility, Copper Valley Telecom, Cordova Wireless, Cross Wireless, CTC, Custer Telephone, East Kentucky Network (Appalachian Wireless), Enflick, GCI Communications, Google Voice, Illinois Valley Cellular, Inland Cellular, Inteliquent, iWireless, Leaco Rural Telephone Cooperative, Limitless Mobile, Mid-Rivers Communications, MobileNation/SI Wireless, MTA Wireless/Matanuska Kenai, Nemont CDMA, Nemont US UMTS, NewCore Wireless, Nex-Tech Wireless, NNTC Wireless, Northwest Missouri Cellular, Pine Belt Wireless, Pine Cellular, Pioneer Cellular, PTCI, Shelcomm, Silver Star PCS, Snake River PCS, SouthernLINC, SouthernLINC LTE, SRT, STRATA Networks, Standing Rock (SRTI), Thumb Cellular, Triangle Wireless, Union Wireless, U.S. Cellular, United Wireless, Viaero Wireless, Virgin Mobile, West Central Wireless.
10. You agree to indemnify Pfizer Inc and any third parties texting on its behalf in full for all claims, expenses, and damages related to or caused, in whole or in part, by your failure to immediately notify us if you change your telephone number, including but not limited to all claims, expenses, and damages related to or arising under the Telephone Consumer Protection Act.
11. Pfizer Inc may immediately suspend or terminate your participation in the Program if it believes you are in breach of these SMS Terms and Conditions. Your participation in this Program is also subject to termination in the event that your mobile telephone service terminates or lapses. Pfizer Inc reserves the right to modify or discontinue, temporarily or permanently, all or any part of the Program, with or without notice.
12. Pfizer Inc may revise, modify, or amend these SMS Terms and Conditions at any time. Any such revision, modification, or amendment shall take effect when it is posted to Pfizer Inc's website. You agree to review these SMS Terms and Conditions periodically to ensure that you are aware of any changes. Your continued consent to receive text messages will indicate your acceptance of those changes.
On Friday July 26, 2019, the US FDA updated the XELJANZ full prescribing information and posted a statement. Pfizer also issued a media statement announcing that the U.S. full prescribing information for XELJANZ® (tofacitinib)/
As a result of this review, two additional warnings for Mortality and Thrombosis were included in the Boxed Warning and related Warnings and Precautions section of the prescribing information and in the Most Important Information I Should Know section of the patient Medication Guide for XELJANZ/
The new Boxed Warning information regarding Mortality discusses the increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/
The new Boxed Warning information regarding Thrombosis includes information on the risk of blood clots. Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/
Patients should stop taking XELJANZ/
Sudden shortness of breath or difficulty breathing
Chest pain
Swelling, pain, or tenderness in leg or arm
Redness or discoloration in leg or arm
Patients should tell their healthcare provider if they have had blood clots in the veins of their legs, arms, or lungs, or clots in arteries in the past.
Patients should always ask their doctors for medical advice about adverse events. You are encouraged to report adverse events related to Pfizer products by calling
The FDA approved use of XELJANZ for adults with moderately to severely active ulcerative colitis (UC) now recommends use after medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated. Healthcare providers are advised to use the lowest effective dose to maintain response in patients with UC.
If you have any questions about these updates talk to your healthcare provider.
The updated Important Safety Information and Indications for XELJANZ/
It is also important to read the patient Medication Guide you receive with your XELJANZ/
Information about Ongoing Post-Marketing Safety Study
This safety study is being conducted in patients 50 years of age and older with rheumatoid arthritis (RA) with at least one heart disease (cardiovascular) risk factor to evaluate the risk of heart-related events and cancer using XELJANZ at two doses (
XELJANZ/
Serious infections. XELJANZ/
Your healthcare provider should test you for TB before starting and during XELJANZ/
You should not start taking XELJANZ/
Before starting XELJANZ/
think you have an infection or have symptoms of an infection, such as fever, sweating, or chills; cough; blood in phlegm; warm, red, or painful skin or sores on your body; burning when you urinate or urinating more often than normal; muscle aches; shortness of breath; weight loss; diarrhea or stomach pain; or feeling very tired
are being treated for an infection
get a lot of infections or have infections that keep coming back
have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
have TB, or have been in close contact with someone with TB
live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use XELJANZ/
have or have had Hepatitis B or C
After starting XELJANZ/
Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/
Cancer and immune system problems. XELJANZ/
Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).
Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/
Stop taking XELJANZ/
Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ/
Serious allergic reactions have happened in patients taking XELJANZ/
Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ/
Changes in lymphocyte counts. Lymphocytes are white blood cells that help the body fight off infections.
Low neutrophil counts. Neutrophils are white blood cells that help the body fight off infections.
Low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired.
Your healthcare provider should routinely check certain liver tests.
You should not receive XELJANZ/
You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start XELJANZ/
What should I tell my healthcare provider before taking XELJANZ/
Before taking XELJANZ/
have an infection
have had blood clots in the veins of your legs, arms, or lungs, or clots in the arteries in the past
have liver problems
have kidney problems
have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
have had a reaction to tofacitinib or any of the ingredients in XELJANZ/
have recently received or are scheduled to receive a vaccine. People taking XELJANZ/
plan to become pregnant or are pregnant. XELJANZ/
Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ/
plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take XELJANZ/
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider about any other medicines to treat your rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis. You should not take tocilizumab (Actemra®), etanercept (Enbrel®), adalimumab (Humira®), infliximab (Remicade®), rituximab (Rituxan®), abatacept (Orencia®), anakinra (Kineret®), certolizumab (Cimzia®), golimumab (Simponi®), ustekinumab (Stelara®), secukinumab (Cosentyx®), vedolizumab (Entyvio®), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ or
Tell your healthcare provider if you are taking medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.
Taking XELJANZ/XELJANZ XR
Take XELJANZ 2 times a day with or without food.
Take
When you take
For the treatment of psoriatic arthritis, take XELJANZ/
What are other possible side effects of XELJANZ/
Common side effects of XELJANZ/
Common side effects of XELJANZ in ulcerative colitis patients include nasal congestion, sore throat, and runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).
What is XELJANZ/
Adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated
Adults with active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well or cannot be tolerated
XELJANZ is also used to treat:
Adults with moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated
It is not known if XELJANZ/
XELJANZ/
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
XELJANZ may cause serious side effects, including:
Serious infections. XELJANZ can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
Your healthcare provider should test you for TB before starting and during XELJANZ treatment, and monitor you closely for signs and symptoms of TB infection during treatment.
You should not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). People taking the higher dose (
Before starting XELJANZ, tell your healthcare provider if you:
think you have an infection or have symptoms of an infection, such as fever, sweating, or chills; cough; blood in phlegm; warm, red, or painful skin or sores on your body; burning when you urinate or urinating more often than normal; muscle aches; shortness of breath; weight loss; diarrhea or stomach pain; or feeling very tired
are being treated for an infection
get a lot of infections or have infections that keep coming back
have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
have TB, or have been in close contact with someone with TB
live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use XELJANZ. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common
have or have had Hepatitis B or C
After starting XELJANZ, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ can make you more likely to get infections or make worse any infection that you have.
Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ
Cancer and immune system problems. XELJANZ may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen in patients taking XELJANZ. People taking the higher dose (
Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).
Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ
Stop taking XELJANZ/ XELJANZ XR and tell your healthcare provider right away if you have any signs and symptoms of a blood clot such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the leg or arm
Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away and a change in your bowel habits.
Serious allergic reactions have happened in patients taking XELJANZ. If you have swelling of your lips, tongue, throat, or get hives, stop XELJANZ and call your healthcare provider right away.
Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ, and while you take XELJANZ, to check for the following side effects:
Changes in lymphocyte counts. Lymphocytes are white blood cells that help the body fight off infections.
Low neutrophil counts. Neutrophils are white blood cells that help the body fight off infections.
Low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired.
Your healthcare provider should routinely check certain liver tests.
You should not receive XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your XELJANZ treatment for a period of time if needed because of changes in these blood test results.
You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start XELJANZ, and as needed after that.
What should I tell my healthcare provider before taking XELJANZ?
Before taking XELJANZ, tell your healthcare provider about all of your medical conditions, including if you:
have an infection
have had blood clots in the veins of your legs, arms, or lungs, or clots in the arteries in the past.
have liver problems
have kidney problems
have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
have had a reaction to tofacitinib or any of the ingredients in XELJANZ
have recently received or are scheduled to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines
plan to become pregnant or are pregnant. XELJANZ may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ. It is not known if XELJANZ will harm an unborn baby.
Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at
plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take XELJANZ or breastfeed. You should not do both. After you stop your treatment with XELJANZ, do not start breastfeeding again until 18 hours after your last dose of XELJANZ.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider about any other medicines you take to treat your ulcerative colitis. You should not take tocilizumab (Actemra®), etanercept (Enbrel®), adalimumab (Humira®), infliximab (Remicade®), rituximab (Rituxan®), abatacept (Orencia®), anakinra (Kineret®), certolizumab (Cimzia®), golimumab (Simponi®), ustekinumab (Stelara®), secukinumab (Cosentyx®), vedolizumab (Entyvio®), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ. Taking XELJANZ with these medicines may increase your risk of infection.
Tell your healthcare provider if you are taking medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.
Taking XELJANZ
Take XELJANZ 2 times a day with or without food.
Do not take XELJANZ XR for ulcerative colitis.
What are other possible side effects of XELJANZ? XELJANZ may cause serious side effects, including Hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ. Your healthcare provider may do blood tests before you start treatment with XELJANZ and while you are using XELJANZ. Tell your healthcare provider if you have any of the following symptoms of a possible Hepatitis B or C infection: feel very tired, little or no appetite,
Common side effects of XELJANZ in ulcerative colitis patients include nasal congestion, sore throat, and runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).
What is XELJANZ? XELJANZ (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:
Adults with moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated
It is not known if XELJANZ is safe and effective in children or in people with Hepatitis B or C.
XELJANZ is not recommended for people with severe liver problems.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.